title: Study on psychoeducation enhancing results of adherence in patients with schizophrenia (SPERA-S): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Poor adherence to pharmacotherapy negatively affects the course and the outcome of schizophreniaspectrum psychoses, enhancing the risk of relapse. Falloon and coworkers developed a Psychoeducation Program aimed at improving communication and problem-solving abilities in patients and their families. This study set out to evaluate changes in adherence to pharmacotherapy in patients diagnosed with schizophrenia-spectrum psychoses, by comparing one group exposed to the Falloon Psychoeducation Program (FPP) with another group exposed to family supportive therapy with generic information on the disorders.
  
  
  METHODS
  340 patients diagnosed with schizophrenia and related disorders according to standardized criteria from 10 participating units distributed throughout the Italian National Health System (NHS), will be enrolled with 1:1 allocation by the method of blocks of randomized permutations. Patients will be reassessed at 6, 12 and 18 months after start of treatment (duration: 6 months).The primary objective is to evaluate changes in adherence to pharmacotherapy after psychoeducation. Adherence will be assessed at three-month intervals by measuring blood levels of the primary prescribed drug using high pressure liquid chromatography, and via the Medication Adherence Questionnaire and a modified version of the Adherence Interview. Secondary objectives are changes in the frequency of relapse and readmission, as the main indicator of the course of the disorder.Enrolled patients will be allocated to the FPP (yes/no) randomly, 1:1, in a procedure controlled by the coordinating unit; codes will be masked until the conclusion of the protocol (or the occurrence of a severe negative event). The raters will be blind to treatment allocation and will be tested for blinding after treatment completion. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate the missing data. The study started recruitment in February 2013; the total duration of the study is 27 months.
  
  
  CONCLUSIONS
  If the psychoeducation program proves effective in improving adherence to pharmacotherapy and in reducing relapse and readmissions, its application could be proposed as a standard adjunctive psychosocial treatment within the Italian NHS.
  
  
  BACKGROUND
  Protocol Registration System of ClinicalTrials.gov NCT01433094; registered on 20 August 2011; first patient was randomized on 12 February 2013.
authors.affiliation: Department of Education, Psychology, Philosophy - University of Cagliari, Cagliari, Italy. drpetretto@unica.it.
authors.forename: Donatella Rita
authors.initials: DR
authors.lastname: Petretto
authors.forename: Antonio
authors.initials: A
authors.lastname: Preti
authors.forename: Carlo
authors.initials: C
authors.lastname: Zuddas
authors.forename: Franco
authors.initials: F
authors.lastname: Veltro
authors.forename: Marco Bruno Luigi
authors.initials: MB
authors.lastname: Rocchi
authors.forename: Davide
authors.initials: D
authors.lastname: Sisti
authors.forename: Valentina
authors.initials: V
authors.lastname: Martinelli
authors.forename: Mauro Giovanni
authors.initials: MG
authors.lastname: Carta
authors.forename: Carmelo
authors.initials: C
authors.lastname: Masala
mesh_terms: D014150:Antipsychotic Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D017028:Caregivers / Q000523:psychology; D002851:Chromatography, High Pressure Liquid; D002985:Clinical Protocols; D017281:Cost of Illness; D016903:Drug Monitoring / Q000379:methods; D005195:Family Relations; D005240:Feasibility Studies; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D057194:Intention to Treat Analysis; D007558:Italy; D055118:Medication Adherence; D010353:Patient Education as Topic; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D012107:Research Design; D012559:Schizophrenia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents